FENTANYL 50 MICROGRAMS / ML SOLUTION FOR INJECTION - patient leaflet, side effects, dosage

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you get any of side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What FENTANYL Injection is and what is it used for

2. What you need to know before you are given FENTANYL Injection

3. How you will be given FENTANYL Injection

4. Possible side effects

5. How to store FENTANYL Injection

6. Contents of the pack and other information

• 1. What FENTANYL Injection is and what is it used for

This medicine has been prescribed for you for pain control during short operations on its own or together with a sedative to put you to sleep for major operations. At higher doses it can also be useful to slow your breathing rate, which is helpful if you are on a ventilator. It can also be used for the treatment of severe pain, such as during a heart attack.

It contains Fentanyl which belongs to a class of medicines called opioids, which are ‘pain relievers’. This medicine has been prescribed to you and should not be given to anyone else. Opioids can cause addiction and you may get withdrawal symptoms if you stop using it suddenly. Your doctor should have explained how long you will be using it for and when it is appropriate to stop, how to do this safely.

2. what you need to know before you are given fentanyl injection

Fentanyl is a strong opioid and should not be used unless you have previously been prescribed other opioids.

Do not use FENTANYL Injection if:

• you are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6) you have any illness which causes breathing difficulties, for example asthma, chronic bronchitis.
• you are taking, or have taken in the last two weeks, any of the antidepressant medicines called monoamine oxidase inhibitors (MAOIs).

If any of the above applies to you, do not use this medicine and talk to your doctor or pharmacist.

Warnings and precautions

• are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs.
• have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.
• feel you need to receive more of FENTANYL Injection to get the same level of pain relief, this may mean you are becoming tolerant to the effects of this medicine or are becoming addicted to it. Speak to your doctor who will discuss your treatment and may change your dose or switch you to an alternative pain reliever.

Using this medicine regularly, particularly for a long time, can lead to addiction. Your doctor should have explained how long you will be using it for and when it is appropriate to stop, how to do this safely. Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your doctor about your treatment. Addiction can cause withdrawal symptoms when you stop using this medicine. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating. Your doctor will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop using the medicine suddenly as you will be more likely to experience withdrawal symptoms. Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else. Using higher doses or more frequent doses of opioid, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

Also check with your doctor or nurse before using this medicine if you:

• have or have ever had problems with your lungs, liver or kidneys
• have or have ever had an underactive thyroid gland
• have or have ever had a muscle weakness called ‘myasthenia gravis’
• have or have ever had long-term treatment with strong painkillers
• have or have ever had low blood volume
• have had a recent head injury
• are elderly or weak due to ill health
• are in labour as fentanyl can affect your baby’s breathing or may increase your risk of developing pneumonia.

Rapid injections of this type of medicine should not be used in patients who have problems with mental or other brain function. In these patients, the resulting decrease in blood pressure has sometimes resulted in a reduction of blood pressure in the brain.

Your doctor will carefully monitor the amount of FENTANYL Injection they give you. If you are not sure if any of the above applies to you, talk to your doctor or nurse before having FENTANYL Injection.

Special monitoring

• FENTANYL Injection may make you breathe more slowly. Your breathing will be carefully monitored until it returns to normal.
• Your blood pressure and heart rate may also be monitored

Other medicines and FENTANYL Injection

Please tell your doctor or nurse if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription or herbal medicines.

In particular, do not have this medicine and tell your doctor or nurse if you have taken:

• Medicines for depression called ‘monoamine oxidase inhibitors’ (MAOIs) in the past two weeks

If this applies to you, do not have FENTANYL Injection

It is especially important to talk to your doctor or nurse if you are taking any of the following:

• Selective Serotonin Reuptake Inhibitors (SSRIs) or Serotonin Norepinephrine Reuptake Inhibitors (SNRIs) for depression (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine)

The effects of FENTANYL Injection or any of these medicines may be increased when they are taken together

• Other strong medicines for pain, for example ‘opioid analgesics’ such as morphine or codeine
• Medicines for putting you to sleep called ‘anaesthetic agents’
• Medicines for anxiety or to help you sleep such as tranquillisers or sleeping pills
• Medicines that affect your central nervous system (CNS depressants) such as medicine for mental disorders or alcohol
• Medicines for HIV infection (called antiviral protease inhibitors) such as ritonavir, indinavir or saquinivir
• Medicines for treating a fungal infection such as fluconazole or voriconazole

The dose of etomidate and midazolam may need to be reduced if given together with FENTANYL Injection.

You should also tell your doctor if you are taking:

• concomitant use of FENTANYL Injection and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However if your doctor does prescribe FENTANYL Injection together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
• Certain medicines for reducing stomach acid (e.g. cimetidine)
• An antibiotic called ciprofloxacin
• A medicine used to treat heart rhythm disorders called mexiletine
• Anti-sickness medicines called domperidone and metoclopramide

Talk to your doctor before having FENTANYL Injection if you are taking any of these medicines. They may have to change the amount of FENTANYL Injection or the other medicines you are given.

Pregnancy and breast feeding

Do not have FENTANYL Injection if you are pregnant or think you might be pregnant unless you have discussed this with your doctor and the benefits of treatment are considered to outweigh the potential harm to the baby. If you have FENTANYL Injection during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

FENTANYL Injection should not be used during childbirth as it can affect the baby’s breathing. FENTANYL Injection may get into breast milk. Do not breast-feed or use breast milk that has been expressed for 24 hours after having FENTANYL Injection.

Do not have FENTANYL Injection while you are breast-feeding as fentanyl passes into breast milk and will affect your baby. Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

FENTANYL Injection may make you feel sleepy. Do not drive or operate any tools or machines until you are fully alert.

This medicine can affect your ability to drive as it may make you sleepy or dizzy.

• Do not drive while taking this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:

• – The medicine has been prescribed to treat a medical or dental problem and

• – You have taken it according to the instructions given by the prescriber or in the information

provided with the medicine and

• – It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

FENTANYL Injection contains sodium

This medicine contains 3.5mg sodium (main component of cooking/table salt) in each 1ml. This is equivalent to 0.18% of the recommended maximum daily dietary intake of sodium for an adult.

3. how you will be given fentanyl injection

FENTANYL Injection is given by a doctor experienced in using this type of medicine. Check with your doctor or nurse if you are not sure about anything. Your doctor should have discussed with you, how long the course of FENTANYL Injection will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop using the medicine.

How FENTANYL Injection is given

• FENTANYL Injection is given as a drip (infusion) or injection into a vein or a muscle
• You may be given an anaesthetic at the same time
• You may be given other medicines to help with some of the side effects of FENTANYL Injection such as slower heart rate and rigid muscles

How much FENTANYL Injection is given

Your doctor will decide how much FENTANYL Injection you need.

This may depend on:

• Your body weight in kilograms
• Your general health
• Your age
• The reason you are being given it
• Other medication

FENTANYL Injection given by injection

If you are to breathe by yourself

• adults and children aged 12 to 17 years old:

• – You will usually be given an initial dose of 50 – 200 micrograms

• – If necessary, you will be given further injections of 50 micrograms during the operation

• children aged 2 to 11 years old:

• – You will usually be given an initial dose of 1–3 micrograms per kilogram

• – If necessary, you will be given further injections of 1–1.25 microgram per kilogram during the operation

When your breathing is helped by a machine (ventilator)

– The initial dose will be 300 – 3500 micrograms

• – If necessary, further injections of 100 – 200 micrograms will be given during the operation

• children aged 2 to 11 years old:

• – You will usually be given an initial dose of 1–3 micrograms per kilogram

• – If necessary, you will be given further injections of 1–1.25 micrograms per kilogram during the operation

FENTANYL Injection given as a drip (infusion)

• The dose of FENTANYL Injection is based on body weight in kilograms
• You may be given an initial dose of 1 microgram per kilogram during each minute for the first 10 minutes
• If necessary, this may be followed by 0.1 micrograms per kilogram during each minute of your operation
• The drip will normally be stopped 40 minutes before the end of your operation

Elderly patients

Less FENTANYL Injection may be used in patients that are elderly or weak due to ill health.

If you think you have been given more FENTANYL Injection than you should:

As this medicine will be given to you whilst you are in hospital, it is unlikely that you will be given too little or too much, however, tell your doctor or nurse if you have any concerns.

Symptoms of overdose: You may feel sleepy, have problems breathing, feel floppy and have cold, clammy skin and very small pupils. It can also affect your heart and blood pressure.

Tell your doctor or healthcare professional if you have any of these side effects so that he/she can give appropriate treatment. If you have already left the medical premises, contact your nearest hospital, doctor or pharmacist.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

If you stop having FENTANYL Injection

Do not suddenly stop having this medicine. If you want to stop having this medicine, discuss this with your doctor first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop using this medicine.

4. possible side effects

Like all medicines FENTANYL Injection can cause side effects, although not everybody gets them. To give you an idea of how many patients might get side effects; they have been listed as very common, common, uncommon and not known. These mean the following:

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

Some side effects can be serious and may require immediate medical treatment:

• Anaphylaxis (severe allergic reaction) with symptoms such as sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties to swallow
• Fits (seizures). (Uncommon, this may affect up to 1 in 100 people.)
• Reduced consciousness or loss of consciousness. (Uncommon, these may affect up to 1 in 100 people.)
• Stopping of the heart (cardiac arrest) (Frequency not know (Cannot be estimated from the available clinical trial data)).

Very Common: Slower breathing, temporary stop of breathing, rigid muscles, feeling or being sick. Common: Muscle twitches, spasm of the throat muscles, dizziness, changes in your heart beat,

high or low blood pressure, vein pain, allergic reactions such as rashes, difficulty in breathing, involuntary movements, sedation, visual disturbances, agitation, postoperative confusion.

Uncommon: Headache, euphoric mood, hallucinations, inflammation of vein, changes in blood

pressure, excess breathing, hiccups or contraction of diaphragm, chills, low body temperature, post-operative agitation.

Not Known: Dependence and addiction (see section “How do I know if I am addicted?” )

Difficulty in sleeping, delirium (symptoms may include a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that are not really there, sleep disturbance, nightmares), symptoms of withdrawal syndrome (may manifest by the occurrence of the following side effects: nausea, vomiting, diarrhoea, anxiety, chills, tremor, and sweating), muscle weakness, shivering, respiratory depression, cough, restlessness and a movement disorder including stiffness, spasms and slow movements, severe itching of the skin (pruritus), itchy skin rash caused by allergic reaction – pale or red irregular raised patches with severe itching (hives).

Drug Withdrawal

When you stop using FENTANYL Injection, you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating.

How do I know if I am addicted?

If you notice any of the following signs whilst using FENTANYL Injection, it could be a sign that you have become addicted.

• – You need to use the medicine for longer than advised by your doctor

• – You feel you need to use more than the recommended dose

• – You are using the medicine for reasons other than prescribed

• – When you stop using the medicine you feel unwell, and you feel better once using the medicine again

If you notice any of these signs, it is important you talk to your doctor.

Reporting of side effects:

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store fentanyl injection

Keep out of the sight and reach of children.

Do not use FENTANYL Injection after the expiry date on the carton. The expiry date refers to the last day of that month. Do not store above 25 °C and keep the container in the outer carton in order to protect from light.

• 6. Content of the pack and other information

What FENTANYL Injection contains:

The active substance is FENTANYL CITRATE, equivalent to 50 micrograms fentanyl per ml.

The solution for injection also contains sodium chloride and water for injections.

What FENTANYL Injection looks like and the contents of the pack:

FENTANYL Injection is a clear colourless solution.

FENTANYL Injection is supplied in cartons of 10 ampoules containing either 100 micrograms/2ml or 500 microgram­s/10ml.

Not all pack sizes may be marketed.

Marketing authorisation holder:

Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex

HA1 4HF, United Kingdom

Manufacturer: SNS Pharmaceuticals Ltd., Mckenzie House, Bury Street, Ruislip, Middlesex, HA4

7TL

This leaflet was last revised in March 2020.

For information in large print, on tape, on CD or in Braille, phone 01271 385257.

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